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Is Lecanemab Plus t-PA A Deadly Combination? One Case Study May Shed Light

Anticoagulant Use In Spotlight As Approval Nears

 
• By Mandy Jackson

A letter in the New England Journal of Medicine suggests the death of one extension trial participant treated with t-PA may have been caused by lecanemab, but a response notes fatal intracerebral hemorrhages have been seen after t-PA in certain patients in the absence of anti-amyloid drugs.

CT scan of brain with red area ( Imaging for hemorrhagic stroke or Ischemic stroke ( infarction ) concept )
Lethal brain hemorrhage has been observed in three lecanemab trial participants, including one who received placebo • Source: Shutterstock

Eisai Co., Ltd. and Biogen, Inc. should hear from the US Food and Drug Administration any day now whether the agency will grant accelerated approval for the amyloid protofibril-targeting antibody lecanemab, but one issue looming large over the treatment for early Alzheimer’s disease is how safe it will be for frail, elderly patients – particularly for individuals taking anticoagulants for cardiovascular disease or treated in the emergency room for a stroke. A new case study looking at one lecanemab clinical trial participant who died following anticoagulant use attempts to shed some light on the safety concern.

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
• By Vibha Sharma

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.